Around the Globe: India
Synergy between Pharmacovigilance and Medical Writing to Benefit Patients
Arunima Sen Dey

o many casual observers, pharmacovigilance (PV) and medical writing (MW) can appear as two disconnected pieces in the drug development lifecycle. In many organizations, PV and MW are two different functions, working in two different silos. Different terminology between these two fields doesn’t do much to correct this perception.

While there are undeniably minor differences in the maze of regulatory writing, safety writing, scientific writing, and even pharmacovigilance medical writing, MW is an indispensable part of the drug development lifecycle. So is PV, and the “drug safety” terminology that is frequently and often interchangeably used with it. Some would suggest that drug safety deals more with signal detection and risk management, and PV more with regulatory compliance. Either way, PV and drug safety are the most important gatekeepers of patient safety.

Navigating Synergy between Both Worlds

Even with these intricacies, PV and MW remain the two primary elements that come together to tell the story of a drug as it moves through its lifecycle. The story begins when an investigational new drug application is filed, advances the narrative across different development phases, and continues when the drug is in the market: to illustrate the drug’s benefits, convey its risks, and present important facts in a way that turns data into narrative. Thus, it is imperative to explore the synergy between these two domains to make sure that we are telling the right story in the most meaningful way to benefit the patient, the ultimate consumer.

For ease of thought navigation, we can think of PV (or drug safety) as having two key components: safety reporting (ICSRs and aggregate reports) and safety monitoring (or safety surveillance). Medical writing is intimately related in developing the content of the documents that define, direct, and support these activities.

The pre-marketing and post-marketing phases of this lifecycle feature numerous documents authored by medical writers which address several safety-related topics. Often considered “safety writing” (the common ground of drug safety and medical writing), in the pre-marketing phase these documents include:

  • Development Safety Update Report
  • Risk Management Plan
  • 120-Day Safety Update
  • Safety Surveillance plans
  • Ad hoc safety review document
  • Responses to health authority questions
  • Special safety white papers/literature safety reviews.

In the post-marketing phase, the most common documents are the Periodic Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), Pediatric Adverse Event Reports (PAER), and risk management plans.

Some may suggest that the purview of core regulatory medical writing is slightly different and is more often than not associated with successful drug submissions. Study protocols, Investigator Brochures (IB), Clinical Study Reports (CSR), and the Common Technical Document (CTD) are among these typical, core regulatory medical writing documents. However, close examination of these documents reveals their interdependence and correlation with PV and drug safety. For example, IBs serve as reference safety information upon which safety surveillance plans are built. Narratives based on safety events comprise a large portion of the CSR, and important CTD modules (i.e., 2.7.4, summary of clinical safety) address drug safety.

Looking through the Business Lens

The COVID-19 pandemic brought new urgency to the field of global vaccine development, and to the MW and PV services required for their global rollout. Pharmaceutical companies have increasingly outsourced both PV and MW services in recent years. The global medical writing market size was valued at USD $3.5B in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 10.41% from 2022 to 2030. The global pharmacovigilance market size was valued at USD $7.8B in 2022 and is expected to expand at a CAGR of 10.3% from 2023 to 2030 (see Market Analysis Report, Grand View Research). Other advances in software and services have also increased momentum for the PV service industry (Market Research Report, Fortune Business Insights).

This growth in both domains (MW and PV) can be primarily attributed to the rise in outsourcing and R&D investment.

India is among the leading countries as a source of Contract Research Organizations (CROs) that cater to the MW and PV needs of pharmaceutical companies. Cost is one reason, but the availability of trained, qualified professional resources delivering efficient outcomes has proven just as important.

Forward into the Future

Given the huge role this service industry plays in delivering work related to the PV and MW domains, it is of paramount importance that we are sensitive to the interdependence and inter-relatedness of these two domains at the organizational level.

Bringing PV and MW together under the same organizational structure, under the same leadership, helps communicate the “big-picture message” that patient safety is of utmost importance for a sponsor.

In such a structure, establishing synergy between the domains becomes easier. Access to a missing source document needed to write a safety report becomes quicker, and writers can quickly check their understanding of safety by consulting the medical resources in the PV department. Narratives can come together more efficiently when these teams can work together. In my personal experience, this model works to effectively bridge the gaps between the workflows of both domains and delivers better outcomes for all.

For example: If safety professionals learn how the data from the ICSRs which are entered into the study database ultimately translate into the narrative that can ensure the safety of a patient either in a clinical trial or as a consumer, their job not only becomes more meaningful, but it may also improve the quality of their work.

As professionals and as organizations working in drug development, our aim remains the same: to ensure patient safety, whether that drug is in development or on the market. We work toward this aim in a multitude of ways: by making sure our studies are designed for patient safety; properly documenting all possible adverse reactions; understanding and documenting the benefits and risks inherent in that drug; and continuing this cycle of monitoring and documentation throughout the drug lifecycle. Reaching this aim is possible if we synergize the two different yet closely related domains of medical writing and pharmacovigilance.

This article reflects both the authors’ opinions and discussions with trade associations. References available on request.